BeiGene, Novartis' PD-1 tislelizumab beats chemotherapy in esophageal cancer

BeiGene CEO John Oyler has pointed to Asian-prevalent cancer types, including gastrointestinal cancers such as esophageal cancer, as areas where tislelizumab has an opportunity to compete with PD-1/L1 market leaders. (BeiGene)

BeiGene has more positive results to report for its PD-1 cancer drug tislelizumab, which Novartis just in-licensed in a deal worth up to $2.2 billion.

In a phase 3 trial, tislelizumab beat physician’s choice chemotherapy at helping previously treated esophageal cancer patients live longer, BeiGene said Wednesday. The company plans to take the results to regulators for potential approval and present them in detail at an upcoming medical conference.

The Rationale 302 results—focused specifically on patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC)—marked the second win for the Chinese-made med in a global pivotal trial. In November, BeiGene said an interim analysis of the Rationale 303 trial had found tislelizumab helped previously treated non-small cell lung cancer patients live longer compared with the chemotherapy docetaxel.

ESCC is the most common subtype of esophageal cancer. There, tislelizumab isn’t too far behind PD-1 leaders such as Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo. Keytruda got its FDA go-ahead in recurrent ESCC in July 2019, though it’s limited to PD-L1-positive cases. Opdivo followed up with an approval last June for recurrent disease regardless of PD-L1 expression status.

Right now, both Keytruda and Opdivo have chemo-combo data out in previously untreated esophageal cancer. With an FDA priority review, Keytruda’s looking at a potential approval by April 13. BeiGene’s closely behind in the front-line setting, too; a global phase 3 trial testing tislelizumab alongside chemotherapy could read out later this year.

In a recent interview, BeiGene CEO John Oyler pointed to Asian-prevalent cancer types, including gastrointestinal cancers such as ESCC, as areas where tislelizumab has a relatively clear opportunity at competing with established market leaders.

“These are areas in which there’s not a lot of competition,” Oyler said at the time. “We’re actually in the very first wave in those areas, and I think if we drive toward those approvals we’re not in a crowded space.”

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Tislelizumab was first approved in China in late 2019 in the small indication of third-line classical Hodgkin’s lymphoma. Just a few days ago, the PD-1 inhibitor—used in tandem with two chemo regimens—added first-line squamous NSCLC to its Chinese label based on tumor progression data from a China-specific trial. And its use in front-line non-squamous NSCLC is under review by Chinese authorities.

Overall, tislelizumab boasts 15 potentially registration-enabling clinical trials in China and globally. Its first ex-China filing is expected in 2021, though the planned indication remains unknown. The broad range of pivotal trials, the potential for a near-term approval, as well as existing positive data readouts, prompted Novartis to shell out $650 million upfront and commit up to $1.55 billion in milestones for major ex-China rights.

RELATED: ESMO: Merck's Keytruda pushes for 2nd esophageal cancer nod with first-line survival win

China’s also known for its relatively low drug prices compared with Western countries. Tislelizumab first entered the Chinese market at a third of Keytruda’s cost in the country after patient financial assistance. This has led to suggestions—including from BeiGene management—that tislelizumab could compete on pricing elsewhere.

Novartis CEO Vas Narasimhan, talking to investors on a conference call on Tuesday, said it’s premature to comment on pricing and strategies of tislelizumab, especially given that the deal hasn’t closed. He did point out that Novartis has a number of combination studies planned across its own oncology portfolio.